1. Field of the Invention
The invention relates to a cuffed-catheter removal device. More particularly, the invention relates to a C-shaped cuffed-catheter removal device facilitating convenient and reliable removal of cuffed or tunneled catheters.
2. Description of the Prior Art
In the USA, there ate more than 5 million central venous catheters (CVC) inserted each year. CVCs are surgically implanted in a patient when it is necessary to deliver IV fluids, parenteral nutrition, antibiotics, chemotherapy, blood products, obtain blood samples, perform plasma pheresis and provide access for hemodialysis treatment. Central venous catheters are available in several different configurations depending upon patient indication, patient anatomy and indwelling time requirements. Specific CVC configurations are (i) PICCs (ii) Tunneled or cuffed Catheters, (iii) Ports (iv) Midline Catheters and (v) Non-tunneled Catheters.
It is estimated there are approximately 400,000 tunneled or cuffed catheters in the USA, of which 50% are used for hemodialysis treatment access. It is essential tunneled catheters be anchored within the patient. One approach to anchoring the implanted catheter is the placement of a permeable member of the implanted catheter inside the patient to promote tissue in-growth within the permeable member. Typically, the permeable member is a cuff affixed around the catheter tube. These cuffs are commercially known as “Dacron” cuffs.
Implantation of a CVC involves surgically creating a subcutaneous tunnel through the skin and into a blood vessel of the patient, and positioning the cuff midway between the skin entry point and the blood vessel entry point. After a period of time, the surrounding tissue grows into the fabric of the cuff such that the catheter is stabilized in the catheterized location. In addition, the catheterized location and the subcutaneous tunnel are sealed off, preventing foreign bodies from entering the wound and blood from exiting or pooling around the catheter near the exit site, thereby preventing patient infection. While such fabric cuffs are inexpensive to make and are generally effective at stabilizing a catheter, they are also difficult to remove. A common eventuality is that each and every catheter cuff will need to be carefully extracted from the subcutaneous channel to allow for catheter removal from the patient.
In order to remove a catheter from the ingrown subcutaneous tissue, the physician must surgically dissect around the cuff with a scalpel, cutting the subcutaneous tissue surrounding all edges of the cuff into which tissue has grown. Tissue growth occurs substantially transverse to the longitudinal axis of the cuff and around the outer circumference of the cuff In addition, tissue growth occurs at angles oblique to the longitudinal axis of the cuff along both of the cuffs side edges. The physician must cut around the circumference of the cuff and both side edges to completely detach the cuff and free the indwelling catheter.
This is a difficult and time-consuming surgical procedure that tends to result in increased patient bleeding. Prolonged surgical time also increases the risk of infection. The procedure may also contribute to an increased chance of scar tissue build-up within the subcutaneous tissue such that creation of additional subcutaneous catheter tunnels becomes increasingly difficult. Also, because cuffs are sized to provide a snug fit in the subcutaneous area, they are difficult to extract smoothly through the tunnel.
With catheters formed of softer durometer materials, such as urethane and silicone, for example, the risk that the catheter will snap or break apart during the removal procedure increases. The use of such materials also increases the risk the affixed cuff will tend to result in the elongation of the tube and alter its dimensions while placing traction. The stress placed on the proximal end of the catheter during removal from the tunnel is concentrated at the location of the cuff. If the catheter breaks during removal, the physician may have to perform a further procedure to remove the severed distal portion of the catheter left within the patient.
As mentioned above, following tissue in-growth into the CVC cuff, catheters can be removed from the subcutaneous tunnel using one of several techniques. The method used depends upon physician preference and the amount of tissue/cuff in-growth that is present. In some cases, the catheter can be removed by placing traction on the external catheter segment. However, surgical removal is commonly necessary to prevent breaking the catheter if the catheter does not dislodge easily with traction.
Current procedure options for the removal of a cuffed or tunneled CVC are traction removal, blunt dissection and surgical removal. Traction removal involves pulling the external catheter segment downward in a straight line away from the exit site with a series of gentle tugs. When separation of the cuff from the surrounding tissue and/or catheter occurs, there will be a “break-away” feeling. Continuous pulling on the catheter is required to complete the removal. In addition, pressure is applied to the catheter/vein insertion site as needed to control bleeding. If the cuff remains in the subcutaneous tissue, it must be dissected out through a small incision utilizing local anesthesia.
With regard to blunt dissection or removal, the external catheter and the entire subcutaneous catheter course are prepped and draped. Local anesthesia is administered at the exit site and around the cuff site. The position of the cuff is located either by palpation or by observing the position of “dimpling” when traction is applied to the catheter's external segment. Blunt dissection is used to widen the exit site and subsequently to disrupt the fibrin in-growth around the Dacron cuff. This is done initially with a hemostat or blunt needle. It is important to dissect the adherent fibrin sheath, which can be extremely difficult. Practitioners must avoid the use of a scalpel to remove this sheath as this can result in puncture or fragmentation of the catheter, which can subsequently result in catheter or air embolization (in the worst case scenario). In extremely stubborn catheter removal, it is wise to place a wire through the catheter and into the inferior vena cava. Therefore, if for some reason the catheter breaks, it remains on the wire and can't embolize into the heart. Subsequently, it can be retrieved in a controlled fashion using a snare. Once removal using this technique is achieved, pressure is applied to the catheter/vein insertion site as needed to control bleeding and the incision is closed with a suture as needed.
Where surgical removal is employed, the external catheter and the entire subcutaneous catheter course are prepped and draped. Local anesthesia is then administered at the exit site and around the cuff site. The position of the cuff is located either by palpation or by observing the position of “dimpling” when traction is applied to the catheter's external segment. A scalpel is used to dissect tissue in-growth around the Dacron cuff. This must be done carefully so as not to cause significant bleeding and possible catheter dissection which can subsequently result in catheter or air embolization. As with blunt dissection, in an extremely stubborn catheter removal, it is wise to place a wire through the catheter and into the inferior vena cava. Therefore, if for some reason the catheter breaks, it remains on the wire and can't embolize into the heart. Subsequently it can be retrieved in a controlled fashion using a snare. Once the removal is complete, pressure is applied to the catheter/vein insertion site as needed to control bleeding and the incision is closed with a suture as needed.
With the foregoing in mind, a need exists for a removal technique and apparatus overcoming the shortcomings of the prior art. The present invention provides such an apparatus and associated technique.